We use cookies to help provide you with the best possible online experience. By using this site, you agree that we may store and access cookies on your device. You can find out more about how to set your own preferences here.

4. Regulatory Support

Cerbios has more than 30 years of experience and knowledge in successfully submitting DMFs for APIs, HPAIs and Biologics to the major authorities worldwide.

Type II DMFs to the US FDA , DMF or CEP to regulatory authorities in Europe and translated DMFs to the Japanese PMDA through Cerbios’s agent are common practice and a service available for our biotech partners that need this expertise in-house with no need for additional consultants.

The service is offered only in connection with the production of registration and commercial batches.